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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pedicle Screw Placement Guide
510(k) Number K253472
Device Name FIREFLY® Pedicle Screw Navigation Guide
Applicant
Mighty Oak Medical
750 W. Hampden Ave.
Suite 120
Englewood,  CO  80110
Applicant Contact Mark Wylie
Correspondent
Mighty Oak Medical
750 W. Hampden Ave.
Suite 120
Englewood,  CO  80110
Correspondent Contact Mark Wylie
Regulation Number888.3070
Classification Product Code
PQC  
Date Received10/10/2025
Decision Date 02/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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